NCT05866601

Brief Summary

The aim of the main study is to find out the effects on anxiety in physiotherapy students after role playing in the learning of the clinical history.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

7 days

First QC Date

May 10, 2023

Last Update Submit

June 2, 2023

Conditions

Keywords

Medical educationnursing educationphysiotherapyempathyanxiety

Outcome Measures

Primary Outcomes (4)

  • Anxiety Questionnaire called STAI before role playing

    This questionnaire allows the evaluation of trait anxiety (tendency to perceive stimuli as anxiogenic or not) and state anxiety (degree to which there are anxious elements in the person's environment at the time close to the evaluation). The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Both state anxiety and trait anxiety have 20 items for assessment. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score. The Spanish adaptation has adequate psychometric properties. In addition, the scale can be applied in the adolescent population, as well as in university students, with evidence of reliability and validity.

    Through study completion, an average of 12 days

  • Anxiety Questionnaire called STAI after role playing

    This questionnaire allows the evaluation of trait anxiety (tendency to perceive stimuli as anxiogenic or not) and state anxiety (degree to which there are anxious elements in the person's environment at the time close to the evaluation). The response scale is Likert-type with 4 alternatives (in the Spanish adaptation from 0 to 3). Both state anxiety and trait anxiety have 20 items for assessment. Thus, the range of responses goes from 0 to 60, with a higher level of anxiety corresponding to a higher score. The Spanish adaptation has adequate psychometric properties. In addition, the scale can be applied in the adolescent population, as well as in university students, with evidence of reliability and validity.

    Through study completion, an average of 12 days

  • Jefferson scale before role playing

    To determine the empathy levels of nursing students, the validated Jefferson Empathy Scale for health professions students will be used. This scale consists of 20 items, each of which is assessed using a seven-point Likert-type response scale (from 1 = 'strongly disagree' to 7 = 'strongly agree'). These items are divided into three subscales: 'perspective taking' (11 items), which refers to the cognitive aspects of empathy; 'compassionate care' (6 items), which is characterised by a combination of cognitive and affective aspects of empathy; and 'putting oneself in the patient's shoes' (three items), considered the inverse of emotional distancing . Ten of these items are positively worded, while the other 10 are negatively worded and should be reversed. The total scores range from 20 to 140 points. Higher scores reflect higher levels of empathy.

    Through study completion, an average of 12 days

  • Jefferson scale after role playing

    To determine the empathy levels of nursing students, the validated Jefferson Empathy Scale for health professions students will be used. This scale consists of 20 items, each of which is assessed using a seven-point Likert-type response scale (from 1 = 'strongly disagree' to 7 = 'strongly agree'). These items are divided into three subscales: 'perspective taking' (11 items), which refers to the cognitive aspects of empathy; 'compassionate care' (6 items), which is characterised by a combination of cognitive and affective aspects of empathy; and 'putting oneself in the patient's shoes' (three items), considered the inverse of emotional distancing . Ten of these items are positively worded, while the other 10 are negatively worded and should be reversed. The total scores range from 20 to 140 points. Higher scores reflect higher levels of empathy.

    Through study completion, an average of 12 days

Interventions

Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy. Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of empathy and anxiety.

Also known as: Role-plaiyng

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First year physiotherapy students who carry out the role playing of the clinical history.

You may qualify if:

  • Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.

You may not qualify if:

  • Students who do not wish to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eva María Martínez-Jiménez

Madrid, Madrid, 28040, Spain

Location

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Role Playing

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

PsychodramaMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

May 23, 2023

Primary Completion

May 30, 2023

Study Completion

June 2, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations